MAUDE Adverse Event Report: ARTHREX, INC. RETROFUSION SCREW, 20MM; PLATE, FIXATION, BONE

Catalog Number	AR-4157-20
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event include improper bone preparation and/or over-torquing.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device expected but not yet received.
Event or Problem Description
It was reported that during a 2nd and 3rd hammertoe correction procedure, the surgeon was attempting to insert an ar-4157-20, lot 10053198, (b)(4) 20 mm retrofusion screw into the 2nd toe.The screw snapped off upon insertion into the proximal phalanx, the portion of the screw that was in the bone was removed.The surgeon re-drilled up to the first laser line using the 2.0 drill from the kit and another ar-4157-20 lot 10072430 ((b)(4)) 20 mm retrofusion screw was used.The surgeon felt resistance while trying to seat the second screw so he stopped and attempted to remove the screw.The screw subsequently snapped upon removal.The portion of the screw that remained in the patient's bone was unable to be retrieved and was cut flush with the bone with the a pin cutter.Sales rep stated that the surgeon concluded that the patient's bone was extraordinarily hard.
Additional Manufacturer Narrative
Patient demographics (date of birth) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission to reflect device evaluation.Complaint confirmed.The device met all material specifications as received.The evaluation revealed that the returned retrofusion screw is broken at the proximal end.The fracture surface displays evidence of torsional-overload.The most likely cause(s) of this type of event include improper bone preparation and/or over-torquing.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a 2nd and 3rd hammertoe correction procedure, the surgeon was attempting to insert an ar-4157-20, lot 10053198, (b)(4) 20 mm retrofusion screw into the 2nd toe.The screw snapped off upon insertion into the proximal phalanx, the portion of the screw that was in the bone was removed.The surgeon re-drilled up to the first laser line using the 2.0 drill from the kit and another ar-4157-20 lot 10072430 ((b)(4)) 20 mm retrofusion screw was used.The surgeon felt resistance while trying to seat the second screw so he stopped and attempted to remove the screw.The screw subsequently snapped upon removal.The portion of the screw that remained in the patient's bone was unable to be retrieved and was cut flush with the bone with the a pin cutter.Sales rep stated that the surgeon concluded that the patient's bone was extraordinarily hard.

• Brand Name: RETROFUSION SCREW, 20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6236128
• Report Number: 1220246-2016-00597
• Device Sequence Number: 13591615
• Product Code: HRS
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10072430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-4157-20 LOT 10053198 RETRO FUSION SCREW 20 MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Weight: 91